ALS Diagnosis From a Saliva Sample: a Non-coding RNA Analysis Approach

Recruiting

• Conditions: Amyotrophic Lateral Sclerosis; Amyotrophic Lateral Sclerosis, Sporadic
• Interventions: Diagnostic Test: Saliva sample

• Registration Number: NCT05928416
• Lead Sponsor: ZIWIG

Brief Summary

RNALS is a multicentre, transversal, diagnostic and non-interventional study carried out in ALS reference centers; in order to identify a diagnostic signature for Amyotrophic Lateral Sclerosis by analyzing of coding and non-coding RNA contained in patients saliva.

The study population consists of patients with definite or probable amyotrophic lateral sclerosis (ALS) according to the El Escorial criteria ("ALS Subjects" group) and subjects with no neurological history (Control group).

The control group will be made up of caregivers of patients with ALS, and caregivers of patients with a pathology other than ALS.

The ALS patients concerned by the study already benefit from routine medical care in ALS expert centers in France.

The patients concerned by the study will be managed without modification of the care pathway, nor modification of the therapeutic indications, nor modification of the diagnostic or follow-up examinations necessary according to the context, which are carried out according to the recommendations of the HAS, CNGOF.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-23
• Study First Submitted QC: 2023-06-23
• Study First Posted: 2023-07-03
• Study Start: 2023-07-11
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-10
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Patient over 18 years of age,

• Patient from one of the 2 study populations:

  • Diagnosis of definite or probable ALS according to El Escorial criteria ("patients ALS" group) ;
  • Control group

• Patient able to carry out a mouth rinse,

• Patient affiliated to the healthcare system,

• Patient has dated and signed the consent form,

Exclusion Criteria

• Recent (<1 month) or ongoing bacterial or viral infection,
• Known active oral or digestive mycosis,
• Evolving, symptomatic or obvious oral pathology,
• Known pregnancy,
• Patient participating in another clinical research study,
• Patient deprived of liberty by administrative or judicial decision or under guardianship ;
• Subject refusing to take a saliva sample;
• For the control group: direct relationship (siblings, descendants, ascendants) with a patient included in the study;
• For control group: medical history of neurological disease (excluding migraine).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	Saliva sample	300 patients
SLA group	Saliva sample	300 patients

Primary Outcome Measures

Name	Time	Method
Area under the curve (AUC) of the Receiver Operating Curve (ROC)	Through the end of study inclusions, an average of 2 years	Identify a diagnostic signature for Amyotrophic Lateral Sclerosis by analyzing of coding and non-coding RNA contained in the saliva.

Trial Locations

Locations (19)

CHU Strasbourg; 🇫🇷 Strasbourg, Alsace, France

CHU Nantes; 🇫🇷 Saint-Herblain, Loire-Atlantique, France

CHU Caen; 🇫🇷 Caen, France

CHU Bretonneau; 🇫🇷 Tours, France

Hôpital de la Pitié-Salpêtrière; 🇫🇷 Paris, France

CHU Toulouse; 🇫🇷 Toulouse, France

C.H.U. de Saint-Étienne; 🇫🇷 Saint-Étienne, Loire, France

CHU Angers; 🇫🇷 Angers, France

Hôpital Cavale Blanche; 🇫🇷 Brest, France

CHU Bordeaux; 🇫🇷 Bordeaux, France

Hospices Civils de Lyon; 🇫🇷 Bron, Rhône, France

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

CHU Montpellier; 🇫🇷 Montpellier, France

CHU Dupuytren; 🇫🇷 Limoges, France

Hôpital de La Timone; 🇫🇷 Marseille, France

CHRU Lille; 🇫🇷 Lille, France

CHU Nice; 🇫🇷 Nice, France

CHU Rennes; 🇫🇷 Rennes, France

CHU de la Réunion; 🇫🇷 Saint-Pierre, France